Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Open Label, Multicenter, Phase 4 Study for the Comparison of Efficacy of Tiotropium Plus Salmeterol/ Fluticasone Propionate Compared With Tiotropium Alone in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864812
• Other study ID #: 112942
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2009
• Last updated: March 29, 2010
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: The Korean Academy of Tuberculosis and Respiratory Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study title

• A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in COPD patients

Study objectives

• To investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with moderate or severe COPD in Korea

Study Design

• Randomized, open-label, multicenter, parallel-group, two group study

Study assessment

• FEV1

• Inspiratory capacity (IC)

• History of COPD exacerbation

• History of hospitalization for COPD exacerbation and all causes

• QoL (SGRQ-C)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects Aged 40 to 80 years.

• Subjects diagnosed with COPD.

• Tobacco smoking 10 pack-years or more.

• Subjects with post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 65% predicted.

Exclusion Criteria:

• Subjects with a history of physician-diagnosed asthma or a respiratory disorder other than COPD which is clinically significant such as diffuse bilateral bronchiectasis.

• Subjects suffering from serious diseases likely to interfere with the study such as chronic congestive heart failure.

• Subjects who used systemic corticosteroids within 4 weeks prior to study entry.

• Subjects with any malignant disease.

• Subjects with a history of severe glaucoma, urinary tract obstruction.

• Previous lung volume reduction surgery.

• Subjects who are pregnant or breastfeeding.

• Subjects with a known hypersensitivity or intolerance to tiotropium or fluticasone-salmeterol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• tiotropium with fluticasone propionate/salmeterol (FSC)
COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
• tiotropium
COPD patients treated with tiotropium

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Inje university Pusan Paik hospital	Busan
Korea, Republic of	Chonbuk national university hospital	Chunbuk
Korea, Republic of	Chungbuk national university hospital	Chungbuk
Korea, Republic of	Chungnam National University Hospital	Chungnam
Korea, Republic of	Keimyung university dongsan medical center	Daegu
Korea, Republic of	Kyungpook national university hospital	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Hallym University scared heart hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Hospital	Inchon
Korea, Republic of	Incheon St. Mary's Hospital	Inchon
Korea, Republic of	Inha university Hospital	Inchon
Korea, Republic of	Gyeongsang national university hospital	Jinju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Boramae Medical Center	Seoul
Korea, Republic of	Ewha womans university mokdong hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Inje university Seoul Paik Hospital	Seoul
Korea, Republic of	Kangdong Scared heart Hospital	Seoul
Korea, Republic of	Kangnam St. Mary's Hospital	Seoul
Korea, Republic of	Konkuk university hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyunghee university east-west neo medical center	Seoul
Korea, Republic of	Kyunghee university medical center	Seoul
Korea, Republic of	Samsung medical center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Soonchunhyang University hospital	Seoul
Korea, Republic of	St. Paul's Hospital	Seoul
Korea, Republic of	Ajou university hospital	Suwon
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu
Korea, Republic of	Wonju Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
The Korean Academy of Tuberculosis and Respiratory Diseases	GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pre-dose FEV1 from baseline at 24 weeks after treatment		24 weeks	No
Secondary	Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety		24 weeks	Yes